SOJOURN 100% Liquid

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. What Sojourn is and what it is used for
   2. Important information before using Sojourn
   3. Sojourn and other medicines
   4. Using Sojourn with food and drink
   5. Driving and using machines
   6. How to use Sojourn
   7. Possible side effects
   8. Severe, rare side effects (can be life-threatening):
   9. The patient should immediately inform their doctor or nurse:
   10. The patient should inform their doctor or nurse in case of:
   11. Very common side effects (may affect more than 1 in 10 people):
   12. Common side effects (may affect up to 1 in 10 people):
   13. Uncommon side effects (may affect up to 1 in 100 people):
   14. Other side effects (frequency unknown):
   15. Reporting side effects
   16. How to store Sojourn
   17. Contents of the packaging and other information
   18. What Sojourn contains
   19. Marketing authorization holder and manufacturer
   20. Marketing authorization holder
   21. Piramal Critical Care B.V.
   22. Manufacturer
   23. Piramal Critical Care B.V.
   24. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Sojourn, 100%, liquid for steam inhalation
Sevoflurane
You should read the contents of this leaflet carefully before using the medicine, as it contains important information for the patient.
Keep this leaflet, you may need to read it again.
In case of any doubts, you should consult a doctor or nurse.
If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.
Table of contents of the leaflet:
What Sojourn is and what it is used for
Important information before using Sojourn
How to use Sojourn
Possible side effects
How to store Sojourn
Contents of the packaging and other information

What Sojourn is and what it is used for

The active substance of Sojourn is sevoflurane, which is a general anesthetic used during surgical procedures and other interventions.
Sojourn is an inhalation general anesthetic administered as a vapor to be inhaled.
Sojourn is used to induce deep sleep (induction of anesthesia) and to maintain it, as well as to relieve pain in patients undergoing surgical procedures (maintenance of anesthesia). If there is no improvement or the patient feels worse, they should consult their doctor.

Important information before using Sojourn

Sojourn should only be administered by trained medical personnel under the supervision of an anesthesiologist or by an anesthesiologist.
When not to use Sojourn and inform your doctor:
if there are medical reasons why the patient should not receive general anesthesia
if the patient has previously been informed that they should not receive general anesthesia
if the patient is allergic (hypersensitive) to sevoflurane or other anesthetics
if the patient or a family member has experienced a condition called malignant hyperthermia (sudden increase in body temperature and severe muscle contractions) during anesthesia
if the patient has liver disease or has previously used general anesthetics, especially if they were administered multiple times in a short period. Some anesthetics may occasionally cause liver disease, which can cause yellowing of the skin and eyes (jaundice).
if the patient has ever experienced QT prolongation (prolongation of a special time interval in the ECG) or torsades de pointes (a specific type of heart rhythm), which may also be associated with QT prolongation. Sometimes sevoflurane can cause these conditions.
if the patient has a tendency to experience seizures or is at risk of seizures
if the patient has a mitochondrial disease.
Warnings and precautions
Before starting treatment with Sojourn, the patient should discuss with their doctor:
if the patient has used general anesthetics in the past, especially if they were administered multiple times in a short period, the risk of liver disease may be increased
if the patient has another disease unrelated to the operation, especially kidney or heart disease, low blood pressure, severe headaches, nausea or vomiting, or Pompe disease in children (a metabolic disorder). Sevoflurane may cause heart rhythm disturbances, which can be severe in some cases.
if the patient has a specific type of muscle weakness (myasthenia gravis), as patients with this disease are very sensitive to drugs that reduce the frequency and depth of breathing.
if the patient has coronary heart disease
if the patient has hypovolemia (reduced blood volume) or is weakened
if the patient has a neuromuscular disease, especially Duchenne muscular dystrophy
if the patient has increased intracranial pressure, e.g. due to head injury or brain tumor
if the patient has experienced seizures or convulsions, as sevoflurane increases the risk of seizures
if the patient is pregnant or breastfeeding
children
if the patient has Down syndrome.
If any of the above circumstances apply to the patient, they should consult their doctor, nurse, or pharmacist. The patient will then require a thorough examination by the doctor and possibly a change of medication.
The following effects may occur during or after administration of Sojourn 100%, liquid for steam inhalation:
During the induction phase, sevoflurane and similar anesthetics (halogenated anesthetics) may cause coughing. This should be taken into account.
As with other anesthetics, sevoflurane may cause mild mood changes for a few days after administration.
Young children under the age of six are more likely to experience acute confusion (delirium) after waking up from anesthesia. Additionally, children under the age of six are more likely to experience agitation/restlessness after waking up from anesthesia.
Sensitive patients may experience a state of excessive metabolic rate (hypermetabolism) of skeletal muscles, leading to high muscle demand for oxygen due to high CO2 levels in the blood (hypercapnia). This can cause muscle stiffness, rapid heart rate (tachycardia), increased breathing rate (tachypnea), blue discoloration of the lips, tongue, skin, and mucous membranes (cyanosis), heart rhythm disturbances (arrhythmia), and/or unstable blood pressure.
In rare cases, the use of inhalation anesthetics has led to increased potassium levels in the blood (hyperkalemia), which can cause heart rhythm disturbances (arrhythmia) and death in children after surgery. This has been reported in patients with neuromuscular diseases, especially Duchenne muscular dystrophy.
Sevoflurane may cause respiratory depression, which can be exacerbated by narcotic premedication or other drugs that cause respiratory depression. Respiratory function should be monitored and supported if necessary.

Sojourn and other medicines

The patient should inform their doctor about the following medicines they are currently taking or have recently taken:
Medicines or active substances contained in the medicines listed below may interact with each other when used concomitantly with Sojourn. Some of these medicines are administered to the patient by the anesthesiologist during surgery, as indicated in the description.
amphetamines (stimulants): used to treat attention deficit hyperactivity disorder (ADHD) or narcolepsy
cardiac medicines, such as adrenaline or epinephrine
beta-adrenergic blockers (e.g. atenolol, propranolol). These are cardiac medicines often used to treat high blood pressure.
alcohol
barbiturates (sleeping pills)
St. John's Wort (a herbal preparation used to treat depression)
constricting medicines (ephedrine): used as decongestants and often contained in cough and cold medicines.
non-selective monoamine oxidase inhibitors (MAOIs) (a group of antidepressant medicines)
calcium antagonists
verapamil (a cardiac medicine used to treat high blood pressure or heart rhythm disorders)
sedatives (benzodiazepines, e.g. diazepam, lorazepam). These are sedatives with a calming effect. They are used when the patient is anxious, e.g. before surgery.
strong painkillers, such as morphine or codeine
muscle relaxants (non-depolarizing, e.g. vecuronium, pancuronium, atracurium, and depolarizing, e.g. succinylcholine): These medicines are used in general anesthesia to relax muscles.
isoniazid, used to treat tuberculosis
isoprenaline

• other anesthetics, e.g. nitrous oxide: This is a medicine used during general anesthesia that induces sleep and relieves pain; propofol, opioids (e.g. alfentanil and sufentanil): These are strong painkillers and are often used during general anesthesia, and sevoflurane may affect their action if they are administered at the same time.

The patient should inform their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any over-the-counter medicines. They should also inform about any herbal medicinal products, vitamins, and minerals they are taking.

Using Sojourn with food and drink

Sojourn, 100%, liquid for steam inhalation, is a medicine that induces and maintains sleep in the patient to allow for surgical procedures. The patient should ask their doctor, surgeon, or anesthesiologist when and what they can eat or drink after waking up from anesthesia.
Pregnancy and breastfeeding
If the patient is pregnant, thinks they may be pregnant, or is breastfeeding, they should inform their doctor or anesthesiologist. It is not known whether sevoflurane or its metabolites pass into breast milk. It is recommended to stop breastfeeding for 48 hours after administration of sevoflurane and discard the milk produced during this period. Sojourn 100% liquid for steam inhalation should not be used in pregnant women unless absolutely necessary.
The use of sevoflurane for anesthesia during cesarean section is safe for both the patient and their child. The safety of sevoflurane during contractions and natural childbirth has not been established. Like other anesthetics, sevoflurane may cause a decrease in respiratory rate in newborns. In this case, the doctor will decide whether sevoflurane can be used.

Driving and using machines

Sojourn, 100%, liquid for steam inhalation, has a significant impact on the ability to drive and use machines. The patient should not drive or operate any machines until their doctor informs them that it is safe.
Receiving general anesthesia may impair the patient's physical and mental abilities for several days. This can impair their ability to perform tasks that require proper concentration. The patient should ask their anesthesiologist when they can safely drive and use machines again.

How to use Sojourn

Sojourn is administered only in a hospital setting by a trained anesthesiologist who will determine the appropriate dose and duration of sevoflurane administration for the patient. The dose will vary depending on the patient's age, weight, type of surgical procedure, and other medicines administered during surgery.
Sojourn in the form of a liquid turns into a gas in a vaporizer and is inhaled by the patient for anesthesia.
It can be used to induce sleep in the patient before surgery or, if the patient has been put to sleep by injection, to maintain anesthesia during surgery.
When the anesthesiologist stops administering Sojourn to the patient, the patient will wake up within a few minutes.
In case of any further doubts about the use of this medicine, the patient should consult their anesthesiologist or nurse.
Using more than the recommended dose of Sojourn
Sojourn will be administered to the patient by medical personnel, and it is unlikely that the patient will receive too much Sojourn. If the patient receives too much Sojourn, the anesthesiologist will take the necessary actions.

Possible side effects

Like all medicines, Sojourn can cause side effects, although not everybody gets them. The patient should immediately inform their doctor, nurse, or anesthesiologist if they do not feel well.

Severe, rare side effects (can be life-threatening):

• anaphylactic or anaphylactoid reactions (see "Side effects of unknown frequency" below)

The following side effects are severe and may require immediate medical attention. During anesthesia, the patient is under medical supervision and will receive immediate help if necessary.

The patient should immediately inform their doctor or nurse:

if they have an allergic reaction, which can be severe, with swelling of the face, tongue, and throat, and difficulty breathing.
if they experience malignant hyperthermia (very high fever), which requires intensive therapy and can be life-threatening. This condition can occur in any member of the patient's family.
if they have increased potassium levels in the blood (hyperkalemia), which can cause heart rhythm disturbances. Hyperkalemia can lead to death, especially in children after surgery. Such cases have been reported in patients with neuromuscular diseases, especially Duchenne muscular dystrophy.

The patient should inform their doctor or nurse in case of:

Very common side effects (may affect more than 1 in 10 people):

agitation (restlessness) in children
slow heart rate (bradycardia)
low blood pressure
coughing
vomiting and nausea

Common side effects (may affect up to 1 in 10 people):

agitation (restlessness) in adult patients
headache
dizziness
drowsiness
rapid heart rate
high blood pressure
breathing difficulties
airway obstruction
slow and shallow breathing
laryngospasm, respiratory disorders
excessive salivation
hypothermia, shivering
fever
abnormal glucose levels in the blood, abnormal liver function test values, or abnormal white blood cell count, i.e. increased susceptibility to infections
increased fluoride levels in the blood

Uncommon side effects (may affect up to 1 in 100 people):

confusion
heart rhythm and cardiac disorders
atrioventricular block (a conduction disorder in the heart)
respiratory arrest, low oxygen levels, fluid in the pleura
urinary retention and glycosuria
increased creatinine levels in the blood (a indicator of poor kidney function) detected in a blood test

Other side effects (frequency unknown):

asthma
allergic reactions, e.g.:
rash
redness of the skin
hives
itching
swelling of the eyelids, shortness of breath
anaphylactic and anaphylactoid reactions. These reactions develop rapidly and can be life-threatening. Symptoms of anaphylaxis include:
malignant hyperthermia
angioedema (swelling of the skin of the face, limbs, lips, tongue, or throat)
breathing difficulties
low blood pressure
hives
seizures
sudden muscle twitching
cardiac arrest
bronchospasm
shortness of breath or wheezing
apnea
lack of breath
worsening of liver function or hepatitis, characterized by e.g. loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice, and dark urine
dangerously high body temperature
chest discomfort
increased intracranial pressure
irregular heartbeat or palpitations
pancreatitis
increased potassium levels in the blood detected in a blood test
muscle stiffness
jaundice
kidney inflammation (symptoms may include fever, disorientation or drowsiness, rash, swelling, urine that looks more or less normal, and the presence of blood in the urine)
swelling
Sometimes, seizures (convulsions) have been observed. They may occur during or up to one day after administration of Sojourn 100% liquid for steam inhalation. They mainly occur in children and young adults.
In children with Down syndrome who receive sevoflurane, bradycardia (slow heart rate) may occur.
Children with Pompe disease, a congenital disease, may experience irregular heart rhythm during sevoflurane anesthesia.
During or immediately after anesthesia, fluoride levels in the blood may be slightly elevated, but this is not considered harmful and returns to normal quickly.
If any of the side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.
If the patient notices any change in their condition after using sevoflurane, they should inform their doctor or pharmacist. Some side effects may require treatment.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can also be reported directly to the national reporting system, to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

How to store Sojourn

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (month/year) stated on the label of the bottle and the carton. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store the bottle in an upright position.
After first opening, the contents of the bottle should be used within 8 weeks.
Do not store in a refrigerator.
Store the bottle tightly closed due to the volatility of the anesthetic.

Contents of the packaging and other information

What Sojourn contains

Sojourn contains 100% sevoflurane as the active substance. The medicine does not contain any other excipients.
This medicine contains fluorinated greenhouse gases.
Each package contains 380 g of Sevoflurane, which corresponds to 0.0741 tons of CO2 equivalent (GWP = 195).
What Sojourn looks like and what the pack contains
Sojourn is a colorless liquid, packaged in 250 ml brown glass bottles (with or without an outer PVC coating) with a screw cap or a closure with an integrated connector.
Pack sizes: 1 and 6 bottles.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR
Voorschoten
Netherlands

Manufacturer

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR
Voorschoten
Netherlands
OR (only for the UK)
Piramal Critical Care Limited
Suite 4, Ground Floor,
Heathrow Boulevard - East Wing,
280 Bath Road, West Drayton,
UB7 0DQ,
United Kingdom.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria - Sevofluran Piramal 100 % Flüssigkeit zur Herstellung eines Dampfes zur Inhalation
Bulgaria - Sevoflurane Piramal 100% Inhalation Vapour, liquid
Cyprus - Sevoflurane - Piramal
Czech Republic - Sojourn 100% tekutina k přípravě inhalace parou
Denmark - Sojourn
Estonia - Sevoflurane- Piramal, inhalatsiooniaur, vedelik 100%
Germany - Sevofluran Piramal 100 % Flüssigkeit zur Herstellung eines Dampfs zur Inhalation
Greece - Sojourn Sevoflurane 100% Inhalation Vapour, liquid
Hungary - Sevoflurane Piramal folyadék inhalációs gőz képzéséhez
Iceland - Sevoflurane Piramal 100% innöndunargufa, vökvi
Ireland - Sevoflurane 100% Inhalation Vapour, liquid
Italy - Sewofluran Piramal
Latvia - Sevoflurane Piramal 100 % Inhalation Vapour, liquid
Lithuania - Sevoflurane Piramal 100% inhaliaciniai garai skystis
Luxembourg - Sevoflurane 100%
Malta - Sevoflurane 100% Inhalation Vapour, liquid
Netherlands - Sevoflurane 100% (Piramal), Vloeistof voor inhalatiedamp
Norway - Sevoflurane Piramal væske til inhalasjonsdamp
Poland - Sojourn
Portugal - Sevoflurano Ojourn 100% líquido para inalação por vaporização
Slovenia - Sevofluran Piramal 250 ml para za inhaliranje, tekocina
Spain - Sevoflurano Piramal 100% líquido para inhalación del vapor
United Kingdom - Sevoflurane 100% Inhalation Vapour, liquid
Date of last revision of the leaflet:04/2025
-------------------------------------------------------------------------------------------------------------------
Additional information for healthcare professionals can be found in the summary of product characteristics for this product.